ISRCTN11764942已完成未知
Towards targeted dietary support for shift-workers with type 2 diabetes: a mixed-method study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
2021 Protocol article in https://doi.org/10.1111/dme.14714 (added 26/08/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37452826/ (added 20/07/2023)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 27/01/2022:
- •1. Male and female
- •2. Aged between 18 and 60 years old
- •3. Type 2 diabetes diagnosed by healthcare professional
- •4. Diabetes should be managed only by lifestyle (diet, activity), or medications not associated with hypoglycemic risk (e.g. acarbose, metformin DPP4 inhibitors, SGLT2 inhibitors)
- •5. Currently work a rotating and/or mixed shift pattern that includes regular night shifts (a minimum of 4 nights per month) as well as other types of shifts (e.g., days, early, or late shifts). A night shift is defined as a period of work between 11 pm and 6 am. The monitoring period needs to include 3-night shifts (either arranged in 3 consecutive night shifts or 2 consecutive night shifts and another single night shift), another type of shift (for example, day or early shifts), and rest days
- •6. Work in a hospital or residential care setting - any job role. Healthcare sector employees represent one of the largest employers of night workers in the UK.
- •7. Not diagnosed with or currently requiring active treatment (e.g. chemotherapy, immunotherapy, or radiotherapy for cancer) for any of the following conditions: heart attack, stroke, angina, thrombosis, kidney disease, liver disease, cancer
- •8. No recent history (last 5 years) of excess alcohol intake or substance abuse
- •9. No recent weight change (lost or gained) by more than 3 kg/7 lb (in the last 2 months)
- •10. Not started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation, and hormonal balance, including anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin, or thyroid hormones
- •Previous inclusion criteria as of 21/09/2021:
- •1. Male and female
- •2. Aged between 18 and 60 years old
- •3. Type 2 diabetes diagnosed by healthcare professional
- •4. Diabetes should be managed only by lifestyle (diet, activity), or medications not associated with hypoglycemic risk (e.g. acarbose, metformin DPP4 inhibitors, SGLT2 inhibitors)
- •5. Currently work a rotating and/or mixed shift pattern that includes regular night shifts (a minimum of 4 nights per month) as well as other types of shifts (e.g., days, early or late shifts). A night shift is defined as a period of work between 11 pm and 6 am. The monitoring period needs to include 3-night shifts (either arranged in 3 consecutive night shifts or 2 consecutive night shifts and another single night shift), another type of shift (for example, day or early shifts) and rest days
- •6. Work in a hospital or residential care setting - any job role. (Healthcare sector employees represent one of the largest employers of night workers in the UK.)
- •7. No history of heart attack, stroke, angina, thrombosis, liver or kidney diseases, chronic gastrointestinal disorder or cancer
- •8. No history of excess alcohol intake or substance abuse
- •9. No recent weight change (lost or gained) by more than 3 kg/7 lb (in the last 2 months)
- •10. Not started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including anti-inflammat
排除标准
- •1. Females, who are pregnant or intending to become pregnant, or currently breastfeeding
- •2. Taking medications associated with hypoglycaemia (e.g. insulin, sulphonylureas (such as glicazide or glimepiride)
- •3. No travel arrangements outside UK within the period of data collection - data needs to be collected across a persons typical working period
- •4. Not already participating in a clinical trial - as likely to influence behaviour and/or glucose variability
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